Posted 3 months ago
Validation Engineer/ Specialist
AI Summary
The Validation Engineer/Specialist is responsible for executing all validation activities for assigned projects, including autoclaves and temperature controllers, covering the validation lifecycle, technical documentation, process, gap analysis, risk assessment, and C&Q activities.
About this role
Validation Engineer/ Specialist
Validation & Engineering Group USA (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.
The Validation Engineer/ Specialist will be responsible of all validation activities for the assigned project. This project include the validation of multiple autoclaves and Temperature controllers. Validation Scope may include: Validation Life Cycle, Execution, Technical Documentation, Process, GAP Analysis, Risk Assessment, C&Q activities, among others.
Qualifications
- Bachelor degree in Engineering or Science
- 5 to 10 years of experience required in the medical device, biotechnology or pharmaceutical industry (liquid dosage a PLUS).
- MUST have experience validating autoclaves
- Experience with Validation Life Cycle (Process, Packaging and Cleaning).
- Experience and knowledge in regulations, including GMP.
- Experience developing and conducting efficient processes to meet production demands.
- Excellent technical writing and verbal communication skills are required.
- Excellent detail oriented individual who can identify milestones.
- Great interpersonal and communications skills.
- Able to interact with all areas and clients.
- Proficiency utilizing MS Office Suite (Word, Excel and PowerPoint) is required.
- Available to work extended hours, holidays if require.
- Must be available to travel and work non-standard shifts if necessary.
- Only candidates who qualifies with all requirements will be evaluate.
- Bilingual (Spanish & English) a plus but not necessary.
Additional Information
Validation and Engineering Group, USA Inc. is an Equal Employment Opportunity employer.
Skills
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